Surgical method and system for performing the same

ABSTRACT

A method using a guide to assist in insertion of a helicoidal member in a target biological tissue. The method includes abutting a substantially longitudinally extending portion of the guide against a target tissue exposed surface with the helicoidal member mounted thereto so that at least a portion of the guide is inserted in a helicoidal member passageway substantially parallel to a helicoidal member longitudinal axis of the helicoidal member; adhering the substantially longitudinally extending portion of the guide to the target tissue exposed surface with the helicoidal member longitudinal axis substantially parallel to the target tissue exposed surface; and advancing the helicoidal member in the target biological tissue in a substantially helicoidal movement with the guide remaining substantially fixed relative to the target biological tissue.

FIELD OF THE INVENTION

The present invention relates to general field of surgery. Morespecifically, the present invention is concerned with a surgical methodand a system for performing the same.

BACKGROUND

Some surgical procedures involve insertion of a helicoidal member intotissue, either in the form of an anchor that remains in place at the endof the procedure, or as a needle that is used to insert a suture thread.The helicoidal member is inserted by rotating it about its longitudinalaxis. Once the helicoidal member has its tip inserted in the tissue, therotation advances the helicoidal member in the tissue as the tip movesforward with the rotation. Helicoidal members may be inserted so thattheir longitudinal axis is perpendicular to a tissue surface topenetrate. In such cases, the forces exerted on the instrument used toinsert the anchor help in maintaining the instrument fixed relative tothe tissue surface during the procedure. If needed, the instrument mayalso be fixed relative to the tissue by securing the tip of theinstrument to the tissue.

In some procedures it would be advantageous to insert the helicoidalmember in the tissue with its longitudinal axis parallel to the tissuesurface. After insertion, part of each coil making the helicoidal memberis then outside of the tissue, adjacent the tissue surface, and theremainder of the helicoidal member is embedded in the tissue. Insertionof the helicoidal member, especially in transcatheter procedures, isdifficult to perform as the instrument needs to be kept fixed at apredetermined location, at least for the first few turns of thehelicoidal member during insertion. However, the various forces andtorques exerted on the helicoidal member and the instrument used forinsertion make immobilization of the instrument very difficult.

Mitral valve regurgitation (MR) is a functional heart disease underwhich the valve does not close completely and causes blood to leak backinto the left atrium. This condition increases the workload on the heartand, if left untreated, can lead to irreversible heart damage, cardiacarrhythmia and congestive heart failure. Currently, mitral valve repair,as the intervention is called, requires open heart surgery withcardiopulmonary bypass. Under such conditions, the patient is subjectedto intra- and post-operative trauma that can result in mortalityincrease and that can prevent high-risk individuals from undergoing theintervention. Hence the need to develop alternative procedures such asminimally invasive percutaneous interventions, which would greatlyreduce the trauma and risks associated with conventional surgery,resulting in an increase of the number of potential candidates forrepair, while significantly cutting patient's recovery times from weeksto days. There have been attempts to perform such surgery withhelicoidal anchors inserted at the periphery of the valve, but they havefailed, at least in part because of the problem of instrumentimmobilization described hereinabove.

Against this background, there exists a need in the industry to providenovel surgical methods and systems for performing the same in whichhelicoidal members are inserted in tissues. An object of the presentinvention is therefore to provide such improved methods and systems.

SUMMARY OF THE INVENTION

In a first broad aspect, the invention provides a system for performinga surgical procedure in a target biological tissue, the targetbiological tissue defining a target tissue exposed surface, the systemincluding: a substantially helicoidal member, the helicoidal memberdefining a helicoidal member longitudinal axis and substantiallylongitudinally opposed helicoidal member proximal and distal ends; asubstantially elongated guide positionable so as to be extending atleast partially through the helicoidal member along the helicoidalmember longitudinal axis, the guide defining a guide tip and a guideperipheral surface extending substantially longitudinally from the guidetip, the guide peripheral surface having a peripheral surface cooledportion covering at least part of the guide peripheral surface; acooling subsystem operatively coupled to the guide for selectivelycooling the peripheral surface cooled portion to a temperaturesufficiently low to cause adhesion between the guide and the targetbiological tissue; a driver, the helicoidal member being mounted to thedriver at the helicoidal member proximal end, the driver being operativefor selectively simultaneously rotating the helicoidal member along thehelicoidal member longitudinal axis and allowing the helicoidal memberto advance along the guide in a distally oriented direction; wherein, inoperation, when the cooling subsystem cools the peripheral surfacecooled portion and the latter is positioned to abut against the targettissue exposed surface, the peripheral surface cooled portion adheres tothe target tissue exposed surface so that the driver can operated todrive the helicoidal member into the target biological tissue byrotating the helicoidal member and advancing the helicoidal member alongthe guide with the peripheral surface cooled portion remaining fixedrelative to the target biological tissue.

The invention may also provide a system wherein the helicoidal member isselectively detachable from the driver.

The invention may also provide a system wherein the driver includes adriver lock movable between a locked configuration and an unlockedconfiguration, wherein, in the locked configuration, the helicoidalmember is locked to the driver, and, in the unlocked configuration, thehelicoidal member is detachable from the driver.

The invention may also provide a system wherein the driver includes asubstantially helicoidal thread configured and sized for receiving partof the helicoidal member at the helicoidal member proximal end.

The invention may also provide a system wherein the helicoidal member isprovided with at least one notch substantially longitudinally extendingsubstantially adjacent the helicoidal member proximal end and the driverlock includes a pin insertable in the notch when the helicoidal memberis operatively secured to the driver in the helicoidal thread, the pinbeing selectively removable from the notch, the pin being inserted inthe notch in the locked configuration and the pin being removed from thenotch in the unlocked configuration.

The invention may also provide a system wherein the lock includes a wiresecured to the pin and the pin is mounted in a substantiallylongitudinally extending pin receiving passageway intersecting thehelicoidal threads, the pin being removable from the pin receivingpassageway by pulling on the wire. The pin may be flexible or rigid. Insome embodiments, the pin and wire extend integrrally from each other.

The invention may also provide a system wherein the cooling subsystemincludes a coolant passageway having a portion thereof substantiallyadjacent to the peripheral surface cooled portion, the coolantpassageway being configured for circulating a coolant therethrough tocool the peripheral surface cooled portion.

The invention may also provide a system wherein the cooling subsystemfurther includes a coolant source in a fluid communication relationshipwith the coolant passageway for providing cooled coolant thereto.

The invention may also provide a system wherein the guide is hollow andthe cooling subsystem includes a coolant tube positioned at leastpartially in the guide, the coolant tube defining at least part of thecoolant passageway.

The invention may also provide a system wherein the guide is closed atguide tip and the coolant tube is provided with at least one coolanttube outlet located in the guide substantially adjacent the peripheralsurface cooled portion, the coolant tube having at least a portionthereof that is spaced apart from the guide so that coolant can becirculated from the coolant tube, through the coolant outlet and betweenthe coolant tube and the guide.

The invention may also provide a system further comprising asubstantially elongated catheter defining substantially opposed catheterproximal and distal ends and a catheter lumen extending therebetween,the guide being partially provided in the catheter lumen and protrudingtherefrom at the catheter distal end.

The invention may also provide a system further comprising a hookremovably mountable to the helicoidal member and a suture thread securedto the hook.

The invention may also provide a system wherein the helicoidal member ismade of a hollow tube, the suture thread extending through the hollowtube and the hook engaging the hollow tube at the helicoidal memberdistal end.

The invention may also provide a system wherein the driver is furtheroperative for retracting the helicoidal member in a proximally orienteddirection and the hook is removable from the helicoidal member when thehook is pulled.

The invention may also provide a system wherein the peripheral surfacecooled portion is at least partially substantially flat.

The invention may also provide a system further comprising an insertmounted to the guide, the insert and guide being longitudinally movablerelative to each other.

The invention may also provide a system wherein the insert includes asubstantially resiliently deformable piece of material provided opposedto the peripheral surface cooled portion.

The invention may also provide a system wherein the insert is made of afoam.

The invention may also provide a system wherein the insert includes asubstantially tubular membrane positioned over the guide peripheralsurface, the membrane being provided with apertures in register with theperipheral surface cooled portion.

The invention may also provide a system wherein the insert includes amembrane positioned over the guide peripheral surface opposed to theperipheral surface cooled portion so that the peripheral surface cooledportion is free of the membrane.

The invention may also provide a system further comprising attachmentloops securing the membrane to the guide, the attachment loops extendingcircumferentially around the guide.

The invention may also provide a system wherein the guide defines a pairof substantially longitudinally extending mounting grooves and theinsert defines a pair of substantially longitudinally extending mountingrods each mounted in a respective one of the mounting grooves.

The invention may also provide a system wherein the helicoidal member isinserted through the insert.

The invention may also provide a system wherein the helicoidal memberhas the same shape before and after insertion in the target biologicaltissue.

The invention may also provide a system wherein the helicoidal memberincludes a shape memory material, the helicoidal member changing betweena helicoidal member first configuration and a helicoidal member secondconfiguration at a transition temperature, the transition temperaturebeing between 20 C and 37 C, but other values are within the scope ofthe invention.

The invention may also provide a system wherein the helicoidal memberfirst and second configurations have different pitches.

The invention may also provide a system wherein the helicoidal memberhas a pitch that varies between the helicoidal member proximal anddistal ends.

The invention may also provide a system wherein the pitch is larger atthe helicoidal member distal end than at the helicoidal member proximalend.

In another broad aspect, the invention provides a surgical method usinga guide to assist in insertion of a helicoidal member in a targetbiological tissue, the target biological tissue defining a target tissueexposed surface, the helicoidal member defining a helicoidal memberlongitudinal axis and substantially longitudinally opposed helicoidalmember proximal and distal ends, a helicoidal member passagewayextending longitudinally between the helicoidal member proximal anddistal ends, the guide being substantially elongated and defining aguide tip, the method including: abutting a substantially longitudinallyextending portion of the guide against the target tissue exposed surfacewith the helicoidal member mounted thereto so that at least a portion ofthe guide is inserted in the helicoidal member passageway substantiallyparallel to the helicoidal member longitudinal axis; adhering thesubstantially longitudinally extending portion of the guide to thetarget tissue exposed surface with the helicoidal member longitudinalaxis substantially parallel to the target tissue exposed surface; andadvancing the helicoidal member in the target biological tissue in asubstantially helicoidal movement with the guide remaining substantiallyfixed relative to the target biological tissue.

The invention may also provide a method wherein adhering thesubstantially longitudinally extending portion of the guide to thetarget tissue exposed surface includes cooling at least part of theguide to a predetermined temperature, the predetermined temperaturebeing low enough to cause cryoadhesion between the substantiallylongitudinally extending portion of the guide and the target tissueexposed surface.

The invention may also provide a method wherein the predeterminedtemperature is low enough to allow cryoadhesion, but remains high enoughand is applied for a duration short enough that substantially noirreversible physiological damages are caused to the target biologicaltissue.

The invention may also provide a method wherein the predeterminedtemperature is between 0 and −40 C.

The invention may also provide a method wherein the guide includessuction apertures in the substantially longitudinally extending portionof the guide and wherein adhering the substantially longitudinallyextending portion of the guide to the target tissue exposed surfaceincludes exerting a suction through the suction apertures.

The invention may also provide a method wherein the helicoidal member isbetween the guide tip and the substantially longitudinally extendingportion of the guide before adhering the substantially longitudinallyextending portion of the guide to the target tissue exposed surface.

The invention may also provide a method wherein the substantiallylongitudinally extending portion of the guide is between the guide tipand helicoidal member before adhering the substantially longitudinallyextending portion of the guide to the target tissue exposed surface.

The invention may also provide a method wherein the substantiallylongitudinally extending portion of the guide and the helicoidal memberhave at least portions thereof substantially in register with each otherbefore adhering the substantially longitudinally extending portion ofthe guide to the target tissue exposed surface.

The invention may also provide a method further comprising detaching theguide from the target tissue exposed surface with the helicoidal memberremaining in the target biological tissue and removing the guide fromwithin the helicoidal member passageway.

The invention may also provide a method further comprising delivering aninsert while advancing the helicoidal member so that when the helicoidalmember remains in the target biological tissue, the helicoidal memberengages the insert.

The invention may also provide a method wherein the insert includes amembrane.

The invention may also provide a method wherein the insert includes aresiliently deformable material.

The invention may also provide a method further comprising delivering aprosthesis while advancing the helicoidal member so that when thehelicoidal member remains in the target biological tissue, theprosthesis is secured to the target biological tissue by the helicoidalmember.

The invention may also provide a method wherein the prosthesis includesa cardiac valve.

The invention may also provide a method wherein the helicoidal membersupports a distally provided hook to which a suture thread is secured,the hook being removable from the helicoidal member, the method furthercomprising using the helicoidal member to insert the suture thread in ahelicoidal configuration in the target biological tissue; withdrawingthe helicoidal member from the target biological tissue with the hookhooking the target biological tissue so that the hook and suture threadremain in the target biological tissue; and pulling on the suture threadto tighten the suture thread.

The invention may also provide a method further comprising positioningthe guide at a predetermined location along the target tissue exposedsurface before adhering the substantially longitudinally extendingportion of the guide to the target tissue exposed surface.

The invention may also provide a method further comprising adjusting theshape of the guide before adhering the substantially longitudinallyextending portion of the guide to the target tissue exposed surface.

The invention may also provide a method further comprising inserting acatheter in a mammal in which the target biological tissue is located sothat a catheter distal tip of the catheter is substantially adjacent thetarget tissue exposed surface; and advancing the guide in the catheteruntil at least part of the guide protrudes from the guide.

The invention may also provide a method wherein the target biologicaltissue is a valve annulus.

The invention may also provide a method comprising implanting at leasttwo of the helicoidal members around the valve annulus and tighteningthe valve annulus by pulling the at least two helicoidal member towardseach other.

The invention may also provide a method wherein the method includesimplanting the helicoidal member around the valve annulus and tighteningthe valve annulus by reducing a radius of curvature of the helicoidalmember.

The invention may also provide a method wherein the valve annulus is amitral valve annulus.

The invention may also provide a method wherein the helicoidal memberhas the same shape before and after insertion in the target biologicaltissue.

The invention may also provide a method wherein the helicoidal memberincludes a shape memory material, the helicoidal member changing betweena helicoidal member first configuration and a helicoidal member secondconfiguration at a transition temperature, the transition temperaturebeing between 20 C and 37 C.

The invention may also provide a method wherein the helicoidal memberfirst and second configurations have different pitches.

The invention may also provide a method wherein the helicoidal memberhas a pitch that varies between the helicoidal member proximal anddistal ends.

The invention may also provide a method wherein the pitch is larger atthe helicoidal member distal end than at the helicoidal member proximalend.

The invention may also provide a method wherein the guide is inserted ina deformable sleeve, the sleeve being partially inserted in the suctionapertures.

In yet another broad aspect, the invention provides a system forperforming a surgical procedure in a target biological tissue using ahelicoidal member, the helicoidal member defining a helicoidal memberlongitudinal axis and substantially longitudinally opposed helicoidalmember proximal and distal ends, the target biological tissue defining atarget tissue exposed surface, the system including: a substantiallyelongated guide positionable so as to be extending at least partiallythrough the helicoidal member along the helicoidal member longitudinalaxis, the guide defining a guide tip and a guide peripheral surfaceextending substantially longitudinally from the guide tip, the guideperipheral surface having a peripheral surface cooled portion; a coolingsubsystem operatively coupled to the guide for selectively cooling theperipheral surface cooled portion to a temperature sufficiently low tocause adhesion between the guide and the target biological tissue; adriver, the helicoidal member being mountable to the driver at thehelicoidal member proximal end, the driver being operative forselectively simultaneously rotating the helicoidal member along thehelicoidal member longitudinal axis and advancing the helicoidal memberalong the guide in a distally oriented direction; wherein, in operation,when the cooling subsystem cools the peripheral surface cooled portionand the latter is positioned to abut against the target tissue exposedsurface, the peripheral surface cooled portion adheres to the targettissue exposed surface so that the driver can operated to advance thehelicoidal member along the guide while driving the helicoidal memberinto the target biological tissue with the peripheral surface cooledportion remaining fixed relative to the target biological tissue.

Advantageously, the present system and method use a guide that can besafely secured to tissue to penetrate so that the helicoidal member canbe inserted therein at a predetermined location. The proposed instrumentcan also be manufactured using known methods and materials at areasonable cost.

The present application claims priority from U.S. Provisional patentapplications 62/094,151 filed 19 Dec. 2014 and 62/186,708 filed 30 Jun.2015, the contents of which is hereby incorporated by reference in itsentirety.

Other objects, advantages and features of the present invention willbecome more apparent upon reading of the following non-restrictivedescription of preferred embodiments thereof, given by way of exampleonly with reference to the accompanying drawings.

BRIEF DESCRIPTION FOR DRAWINGS

In the appended drawings:

FIG. 1, in a perspective view, illustrates a system in accordance withan embodiment of the present invention;

FIG. 2, in a perspective view, illustrates a helicoidal member part ofthe system shown in FIG. 1;

FIG. 3, in a perspective view, illustrates an alternative helicoidalmember usable in the system shown in FIG. 1;

FIG. 4A, in a perspective view, illustrates an alternative guide usablein the system shown in FIG. 1;

FIG. 4B, in a transversal cross-sectional view, illustrates the guideshown in FIG. 4A

FIG. 5A, in a perspective view, illustrates another alternative guideusable in the system shown in FIG. 1;

FIG. 5B, in a transversal cross-sectional view, illustrates the guideshown in FIG. 5A;

FIG. 6A, in a perspective view, illustrates yet another alternativeguide usable in the system shown in FIG. 1;

FIG. 6B, in a transversal cross-sectional view, illustrates the guideshown in FIG. 6A;

FIG. 7, in a cut away perspective view, illustrates the guide part ofthe system shown in FIG. 1.

FIG. 8, in a perspective view, illustrates an attachment and anhelicoidal member both usable in the system of FIG. 1, the helicoidalmember being detached from the attachment;

FIG. 9A, in a perspective view, illustrates the attachment of FIG. 8;

FIG. 9B, in a perspective view, illustrates an alternative attachment;

FIG. 9C, in a perspective view, illustrate an alternative helicoidalmember usable with the attachment of FIG. 9B

FIG. 10, in a perspective view, illustrates the attachment andhelicoidal member of FIG. 8 attached to each other;

FIG. 11, in a perspective view, illustrates yet another alternativeguide and yet another alternative helicoidal member usable in the systemof FIG. 1;

FIG. 12, in a perspective partial view, illustrates the guide andhelicoidal member of FIG. 11;

FIG. 13, in a perspective view, illustrates yet another anotheralternative helicoidal member usable in the system of FIG. 1;

FIG. 14, in a perspective view, illustrates the guide of the system ofFIG. 1 with an insert engaged by the helicoidal member;

FIG. 15A, in a side elevation view, illustrates an alternative insertmountable to a guide;

FIG. 15B, in a front partial cross-sectional view, illustrates theinsert of FIG. 15A mounted to a guide;

FIG. 16A, in a side elevation view, illustrates an other alternativeinsert mountable to a guide;

FIG. 16B, in a front partial cross-sectional view, illustrates theinsert of FIG. 16A mounted to a guide;

FIG. 17A, in a side elevation view, illustrates yet an other alternativeinsert mountable to a guide;

FIG. 17B, in a front partial cross-sectional view, illustrates theinsert of FIG. 17A mounted to a guide;

FIG. 18A, in a perspective view, illustrates yet another alternativeguide usable in a system similar to the system of FIG. 1, the presentguide using suction to adhere to tissue;

FIG. 18B, in a schematic view, illustrate a configuration of suctionapertures usable in the guide of FIG. 18A;

FIG. 18C, in a schematic view, illustrate another configuration ofsuction apertures usable in the guide of FIG. 18A;

FIG. 18D, in a schematic view, illustrate yet another configuration ofsuction apertures usable in the guide of FIG. 18A;

FIG. 18E, in a schematic transversal cross-sectional view, illustratesyet another alternative guide usable in a system similar to the systemof FIG. 1;

FIGS. 19A to 19H, in schematic views, illustrate various cross-sectionalconfiguration usable in a guide similar to the guide of FIG. 18;

FIG. 20, in a flowchart, illustrates a method of using the system ofFIG. 1;

FIGS. 21A to 21C, in schematic views, illustrate successive steps in anannuloplasty procedure performed using the system of FIG. 1;

FIGS. 21D to 21F, in schematic views, alternative embodiments of anannuloplasty procedure performed using the system of FIG. 1;

FIGS. 22A to 22C, in a schematic top view, illustrate variousconfigurations of helicoidal members usable to perform the annuloplastyprocedures shown in FIGS. 21A to 21F;

FIGS. 23A, in a perspective schematic view, illustrates a prosthesis inthe form of a valve leaflet positioned about a valve annulus;

FIG. 23B, in a perspective schematic view, illustrates the prosthesis ofFIG. 23A attached to surrounding tissue with the helicoidal member ofFIG. 2;

FIG. 23C, in a perspective schematic view, illustrates an alternativeprosthesis attached to surrounding tissue with the helicoidal member ofFIG. 2;

FIG. 23D, in a transversal cross-sectional view, illustrates theprosthesis of FIG. 23A attached to a guide usable in the system of FIG.1;

FIGS. 23E to 23G, in schematic views, illustrate successive steps in animplantation of a tubular valve performed using a system similar to thesystem of FIG. 1;

FIG. 23H, in a perspective view, illustrates the tubular valve used inthe procedure illustrated in FIGS. 23E to 23G;

FIGS. 24A to 24D, in a schematic side cross-sectional view, illustratepart of the annuloplasty procedure shown in FIGS. 21A to 21C;

FIG. 24E, in a schematic side cross-sectional view, illustrate analternative positioning of a guide to perform the annuloplasty procedureshown in FIGS. 21A to 21C;

FIGS. 25A to 25H, in schematic views, illustrate successive step in aprocedure in which the system 10 is used to close a gap between twotissue portions;

FIG. 26, in an exploded view with parts removed, illustrates the systemof FIG. 1; and

FIG. 27, in a longitudinal cross-sectional view with parts removed,illustrates the system of FIG. 1.

DETAILED DESCRIPTION

With reference to FIG. 1, there is shown a system 10 for performing asurgical procedure in a target biological tissue 12 (shown onlyschematically in FIG. 1). The target biological tissue 12 defines atarget tissue exposed surface 14. The target tissue exposed surface 14is either at the surface of a subject on which the surgical procedure isperformed, and thus exposed to the environment, or in one of thenumerous cavities or vessels present in animals, such as for example andnon-limitingly, the interior of the gastro-intestinal system, the bloodvessels, cardiac chambers and airways. The target tissue exposed surface14 may also be at the junction between two adjacent tissues or tissueportions that can move relative to each other at this junction, forexample within an incision in a tissue. The target tissue exposedsurface 14 is thus any surface that can be accessed to insert somethingin the bulk of the target biological tissue 12, and is typically exposedto gases or fluids.

The system 10 includes a substantially helicoidal member 16. As betterseen in FIG. 2, the helicoidal member 16 defines a helicoidal memberlongitudinal axis 18 and substantially longitudinally opposed helicoidalmember proximal and distal ends 20 and 22. A helicoidal memberpassageway 24 extending longitudinally between the helicoidal memberproximal and distal ends 20 and 22.

In the present document, the terminology distal and proximal refers tothe location relative to an operator (not shown in the drawings) usingthe system 10. Distal elements are closer to the target biologicaltissue 12, while proximal elements are closer to the operator of thesystem 10. This terminology is used to facilitate the description of thesystem 10 and should not be used to restrict the scope of the presentinvention. Also, the terminology “substantially” and “about” is used todenote variations in the thus qualified terms that have no significanteffect on the principle of operation of the system 10. These variationsmay be minor variations in design or variations due to mechanicaltolerances in manufacturing and use of the system 10. These variationsare to be seen with the eye of the reader skilled in the art.

Returning to FIG. 1, the system also includes a substantially elongatedguide 26 positionable so as to be extending at least partially throughthe helicoidal member 16 along the helicoidal member longitudinal axis18. Referring to FIG. 7, the guide 26 defines a guide tip 28 and a guideperipheral surface 30 extending substantially longitudinally from theguide tip 28. The guide peripheral surface 30 has a peripheral surfacecooled portion 32 covering at least part of the guide peripheral surface30. The peripheral surface cooled portion 32 may cover only a small partof the guide peripheral surface 30, or may include most or all of theguide peripheral surface 30.

Returning to FIG. 1, a cooling subsystem 33 is operatively coupled tothe guide 26 for selectively cooling the peripheral surface cooledportion 32 to a temperature sufficiently low to cause adhesion betweenthe guide 26 and the target biological tissue 12. As described infurther details hereinbelow, cooling is for example performed using acoolant that is refrigerated and circulated in the guide 26. Inalternative embodiments, the peripheral surface cooled portion 32 is incontact with a Pelletier device that cools the peripheral surface cooledportion 32. Any other suitable cooling method may also be used to coolthe peripheral surface cooled portion 32, such as for example andnon-limitingly, evaporative cooling of a liquid provided in the guide26, or by phase change of a material provided in the guide 26 so that itmay absorb heat from adjacent tissue.

Returning to FIG. 7, the helicoidal member 16 is mounted to a driver 34at the helicoidal member proximal end 20. The driver 34 is operative forselectively simultaneously rotating the helicoidal member 16 along thehelicoidal member longitudinal axis 18 and advancing the helicoidalmember 16 along the guide 26 in a distally oriented direction. In someembodiments, the driver 34 is configured so that the helicoidal member16 is actively advanced while rotated. In other embodiments, the driver34 is simply free to move longitudinally and is advanced by thehelicoidal member 16 as the latter advances in the target biologicaltissue 12 due to rotation of the helicoidal member 16.

In operation, when the cooling subsystem 33 cools the peripheral surfacecooled portion 32 and the latter is positioned to abut against thetarget tissue exposed surface 14, the peripheral surface cooled portion32 adheres to the target tissue exposed surface 14 so that the driver 34can operated to advance the helicoidal member 16 along the guide 26while driving the helicoidal member 16 into the target biological tissue12 with the peripheral surface cooled portion 32 remaining fixedrelative to the target biological tissue 12.

More specifically, the guide 26 abuts on the target tissue exposedsurface 14 from the side, as opposed from abutting from the guide tip28. The helicoidal member longitudinal axis 18 and the target tissueexposed surface 14 are substantially parallel to each other. Theperipheral surface cooled portion 32 is from a substantiallylongitudinally extending portion of the guide 26. The peripheral surfacecooled portion 32 may reach the guide tip 28 or may be spaced aparttherefrom longitudinally. Due to its helicoidal shape, rotating thehelicoidal member 16 causes the latter advances in the target tissue ina corkscrew-like motion. It was found that, surprisingly, cryoadhesionof the guide 26 provides sufficient adhesion in this configuration toallow driving the helicoidal member 16 into the target biological tissue12 as described even with the relatively large forces and torquesinvolved in advancing the helicoidal member 16.

The system 10 is particularly useful in surgical procedures that areperformed away from the target biological tissue 12, for example througha laparoscopy, percutaneous or a transcatheter procedure. In this lattercase, as see in FIG. 1, the system 10 also includes a substantiallyelongated catheter 36 defining substantially opposed catheter proximaland distal ends 38 and 40 and a catheter lumen 42 (seen in FIG. 7)extending therebetween. The guide 26 protrudes from the catheter lumen42 at the catheter distal end 40. However, the present invention mayalso be used without the catheter 36 when easy access to the targetbiological tissue 12 exists.

The guide 26 is substantially elongated and is typically connected to aguide actuator 44. The guide actuator 44 extends along the catheter 36in the catheter lumen 42 to the catheter proximal end 38 and islongitudinally movable therealong. The guide actuator 44 has a rigiditysufficient to be movable substantially longitudinally along the catheter36 so that the guide 26 protrudes more or less therefrom, but isnevertheless sufficiently flexible to follow the shape of the catheter36 inside the patient, for example around the vasculature in the case ofcardiac interventions. The guide actuator 44 terminates with a guideactuator handle 46 that allows controlling the longitudinal position ofthe guide 26. In some embodiments, the guide actuator 44 issubstantially tubular with circular transversal cross-section to allowcirculation of coolant fluid therethrough, as further describedhereinbelow. In some embodiments, the guide actuator 44 and the guide 26extend integrally from each other.

The guide 26 may have any suitable transversal cross-sectionalconfiguration. For example, the guide 26 has a substantially ovaltransversal cross-sectional configuration, as shown in FIG. 1. In otherembodiments, as shown for guides 26 a to 26 c shown respectively inFIGS. 4A, 5A and 6A, the guide may have substantially, rectangular,T-shaped or D-shaped, transversal cross-sectional configurations, amongother possibilities. These transversal cross-sectional configurationsare better illustrated in FIGS. 4B, 5B and 6B, respectively. In yetanother embodiments, shown in FIGS. 11 to 13, a guide 26 d had asubstantially circular transversal cross-sectional configurations. Forexample, D-shaped configuration of guide 26 c allows a substantiallyflat peripheral surface cooled portion 32 c, which may contactefficiently substantially flat target tissue exposed surfaces 14. Also,the T-shaped transversal cross-sectional configuration of the guide 26 ballows for peripheral surface cooled portion 32 b having a pair of flatportions 35 spaced apart laterally from each other with a U-shapedportion 37 extending therefrom and therebetween. The U-shaped portion 37may be inserted in the space between two tissue portions to attach toeach other with minimal or no gap therebetween, each of the flatportions 35 abutting against one of the tissue portions. The exact sizeand cross sectional configuration of the guides 26, 26 a, 26 b, 26 c and26 d allow control over the depth of insertion of the helicoidal member16.

In some embodiments, the guide 26 is substantially rigid so that itremains with a substantially constant shape while in use. This shape maybe substantially rectilinear or curved, among other possibilities. Inother embodiments, the guide 26 is deformable so that its shape can beadjusted (not shown in the drawings). An exemplary deformation is from alinear configuration to an arcuate configuration and is accomplishedusing mechanical and/ or electrical devices known to those skilled inthe art. In these embodiments, the guide 26 may be either entirelydeformable, or may have a section thereof that is more deformable thanthe remainder of the guide 26. Deformation of the guide 26 may beeffected for example by using a tether secured to the guide tip 28 andextending in a distally oriented direction therefrom and returningthrough the catheter lumen 42. In other embodiments, the tether isinserted in a separate lumen traversing the guide 26 and guide actuator44. The tether and can be pulled onto by the intended user of the system10 to bend the guide 26. In other embodiments, one, two or more pairs oflaterally opposed cables are secured to the guide tip 28 and extendthrough the catheter lumen 42 to the catheter proximal end 38. Pullingon these cables allow bending of the guide 26, for example using abending actuator 47. The guide 26 may also be deformed using any othersuitable mechanism. Such mechanisms for remotely adjusting the shape ofa member at the end of a catheter are known in the art and are notdescribed in further details herein.

In yet other embodiments, when not constrained, the guide 26 achieves ashape suitable for its intended purpose. The guide 26 is howeverdeformable passively to allow for example passage through the catheter36 as the latter is advanced through a patient's vasculature. In otherwords, once deployed adjacent the target biological tissue 12, the guide26 achieves the shape required for the specific surgical interventionpracticed. However, the guide 26 may deform to allow reaching the targetbiological tissue, due for examples to curves in the catheter 36. Anexample of such a guide 26 may be substantially arc segment shape foruse in valve annuloplasty. The guide26 can be shaped by insertingpre-shaped flexible longitudinal inserts thereinto.

Referring to FIG. 7, the guide 26 is typically hollow to define a guidecavity 49 thereinto and extends from the guide actuator 44, which isalso hollow typically. The guide cavity 49 is closed at the guide tip 28by a guide end wall 48. The guide peripheral surface 30 extends from theguide end wall 48. The guide 26 is relatively highly thermallyconductive at least in the peripheral wall cooled portion 32. Forexample, the peripheral wall cooled portion 32 is made of metal or anyheat conductive material or combination of heat conductive materialsthat is in contact with the coolant or that is in contact with any othercooled material. In some embodiments, creating a flexible metallic guidecan be made using below type constructions or using a series of metallicrings intertwined by a polymer.

The cooling subsystem 33 includes a coolant source 50 (shown in FIG. 1).The coolant source 50 is in a fluid communication relationship with acoolant passageway 52, seen in FIG. 7, for providing cooled coolantthereto. The coolant passageway has a portion thereof substantiallyadjacent to the peripheral surface cooled portion 32 and in a thermaltransfer relationship therewith. The coolant passageway 52 is configuredfor circulating a coolant therethrough to cool the peripheral surfacecooled portion 32.

The coolant source 50 is a conventional device that is used to cool aconventional coolant, such as the those used in cryosurgery. In someembodiments, the temperature to which the coolant is cooled iscontrolled so that no or only minimal irreversible damages are caused inthe target biological tissue 12. In other embodiments, the targetbiological tissue 12 may be cooled with some damages without affectingthe normal physiology of an organ including the target biological tissue12. The coolant source 50 typically also includes a pump to circulatethe coolant through the coolant passageway 52. The coolant can be aliquid or a gas or a change of phase can occur in the guide cavity 49.

In some embodiments, temperature control is made by supplying to thecoolant passageway 52 coolant at a predetermined temperature. In otherembodiments (not shown in the drawings), the coolant source 50 isoperatively coupled to a temperature sensor, such as a thermocouple, atthe peripheral surface cooled portion 32 so that the temperature of thelatter can be controlled by supplying cooler or warmer coolant to thecoolant passageway 52.

In some embodiments, the coolant passageway 52 is formed as follows. Acoolant tube 54, which forms part of the coolant passageway 52, extendsin the guide 26 along a portion thereof. The coolant tube 54 may alsoextends along the catheter 36 when the latter is provided. The coolanttube 54 is provided with at least one coolant tube outlet 56, and insome embodiments a series of longitudinally spaced apart coolant tubeoutlets 56, located in the guide 26 substantially adjacent theperipheral surface cooled portion 32. The coolant tube outlets 56typically extend substantially radially and proximally relative to theperipheral surface cooled portion 32 so as to provide the coolantdirectly adjacent the peripheral surface cooled portion 32. The coolanttube 54 has at least a portion thereof that is spaced apart from theguide 26 so that coolant can be circulated from the coolant tube 54,through the coolant tube outlets 56 and between the coolant tube 54 andthe guide 26. A coolant return passageway 58 is provided for collectingthe coolant from the interior of the guide 26 and return it to thecoolant source 50 through the catheter 36. For example, the coolant tube54 is of an outside diameter that is slightly smaller than an innerdiameter of the guide 26 so that when the coolant is forced underpressure in the coolant tube 54, the coolant can exit the coolant tubethrough the coolant tube outlets 56 and get to the coolant returnpassageway 58. In other cases the coolant tube 54 diameter is muchsmaller than the inner diameter of the guide 26 to allow for coolantexpansion, thus triggering a decrease in temperature. In someembodiments, the coolant tube outlets 56 are substantially adjacent tothe peripheral surface cooled portion 32 to provide optimal cooling ofthe latter. In some examples, the coolant is returned in a dedicatedcoolant return tube.

In alternative embodiments (not shown), the cooling subsystem 33includes a cooling tube that reaches the interior of the guide 26 andabut against the peripheral surface cooled portion 32. The cooling tubecirculates the coolant in a closed circuit between the guide 26 and thecoolant source 50.

In some embodiments, the helicoidal member 16 has the same shape, orsubstantially the same shape, before and after insertion in the targetbiological tissue 12. In other words, the helicoidal member 16 does notdeform substantially during insertion. In other embodiments, thehelicoidal member 16 includes a shape memory material, for exampleNitinol™ and changes between a helicoidal member first configuration anda helicoidal member second configuration at a transition temperature.For example, the transition temperature is between 20 C and 37 C. Insome embodiments, the helicoidal member first and second configurationshave different pitches. The pitch is defined in the present document asthe longitudinal distance covered when advancing along the helicoidalmember one full turn about the helicoidal member longitudinal axis 18.

In some embodiments, as seen in FIG. 1, the pitch of the helicoidalmember 16 is constant along the whole helicoidal member 16. In otherembodiments, the helicoidal member 16 a has a pitch that varies betweenthe helicoidal member proximal and distal ends 20 and 22, as seen inFIG. 3. In such embodiments, the pitch may be larger at the helicoidalmember distal end 22 than at the helicoidal member proximal end 20. Thisconfiguration provides a compression of the target biological tissue 12as the helicoidal member 16 is advanced thereinto. The helicoidal memberdistal end 22 sharpness is varied depending on target biological tissue12 properties.

The helicoidal member 16 may be metallic. The helicoidal member 16 maybe biodegradable. Also, in some embodiments, the helicoidal member 16may be provided with small tins on its surface or finishing thatincreases the friction with surrounding target biological tissue 12.

As seen for example in FIG. 7, the driver 34 includes an attachment 60for holding the helicoidal member 16, a driver actuator 62 forselectively rotating the driver 34. The driver actuator 62 terminatestypically with a driver handle 64 opposed to the attachment 60. When thecatheter 36 is present, the driver actuator 62 extends thereinto withthe driver handle 64 protruding therefrom. For example, the driveractuator 62 includes is a substantially elongated tube through which theguide 26 and part of the guide actuator 44 are inserted. The attachment60 and guide actuator 62 may extend integrally from each other or be twoseparate components permanently or reversibly secured to each other. Theguide 26/guide actuator 44 assembly and the driver actuator 62 arelongitudinally movable relative to each other. In some embodiments, thedriver actuator 62 includes a braided or coiled catheter to allow goodtorque transfer to the helicoidal member 16.

In some embodiments, as shown in FIG. 1, the helicoidal member 16 ispermanently secured to the driver 34, for example by extendingintegrally therefrom. In other embodiments, as seen in FIGS. 8 to 10,the helicoidal member 16 is selectively detachable from the driver 34 a.A specific embodiment of this latter case is further described in thefollowing paragraphs.

In this embodiment, the driver 34 a includes a driver lock 66 movablebetween a locked configuration (seen in FIG. 10) and an unlockedconfiguration (seen in FIG. 8 with the helicoidal member 16 detachedfrom the driver 34a). In the locked configuration, the helicoidal member16 is locked to the driver 34 a. In the unlocked configuration, thehelicoidal member 16 is detachable from the driver 34a.

For example, as better seen in FIG. 9A, the attachment 60 a defines anattachment passageway 70 opened distally at an attachment passagewaydistal end 72. A substantially helicoidal thread 74 extends into theattachment passageway 70 from attachment passageway distal end 72. Thehelicoidal thread 74 is configured and sized for receiving part of thehelicoidal member 16 or 16 a (not shown in FIG. 9A) at the helicoidalmember proximal end 20. For example, the helicoidal thread 74 has aconfiguration complementary to that of the helicoidal member 16 or 16 aat the helicoidal member proximal end 20 to substantially snugly holdthe helicoidal member 16 in the attachment passageway 70.

The driver lock 66 can be any suitable lock that can prevent detachmentof the helicoidal member 16 from the attachment 60 a. In someembodiments the helicoidal member 16 or 16 a is provided with at leastone notch 76 (better seen in FIG. 3) substantially longitudinallyextending substantially adjacent the helicoidal member proximal end 20and the driver lock includes a pin (or rigid wire) 78 (seen in FIGS. 8an 10) insertable in the notch 76 when the helicoidal member 16 isoperatively secured to the driver 34 in the helicoidal thread 74. Thepin 78 is selectively removable from the notch 76. Removal of the pin 78from the notch 76 unlocks the helicoidal member 16, which can then beremoved by rotating the attachment 34 a and helicoidal member 16relative to each other.

There may be more than one notch 76 provided, all longitudinally alignedalong the helicoidal member 16. For example, the notches 76 are providedat the periphery of the helicoidal member 16 and a substantiallyrectilinear and substantially longitudinally extending pin receivingpassageway 80 may extend in the attachment 60 a, as seen in FIG. 9A. Thepin receiving passageway 80 receives the pin 78 thereinto and intersectsthe helicoidal thread 74 in register with the position of the notches 76when the helicoidal member 16 is operatively secured to the attachment60. The pin 78 is longitudinally movable along the pin receivingpassageway 80.

Removal of the pin 80 from the pin receiving passageway 78 may beperformed in any suitable manner. For example, a wire 82 (seen in FIG.10) is secured to the pin 80 and extends in the catheter 36. The pin 80is removable from the pin receiving passageway 78 by pulling on the wire82.

In another embodiment, as seen in FIG. 9B, the attachment 60 b issubstantially tubular with circular cross-sectional configuration anddefines an attachment passageway 70 b opened distally through which theguide 26 (not seen in FIG. 9A) can pass. A substantially helicoidalthread 74 b is formed on the outer peripheral surface 75 of theattachment 60 b and extends from the attachment distal end 72 b. Thehelicoidal thread 74 b is configured and sized for receiving part of analternative helicoidal member 16 c (seen in FIG. 9C) at the helicoidalmember proximal end 20. The helicoidal member 16 c is similar to thehelicoidal member 16, except that the notches 76 face inwardly. Forexample, the helicoidal thread 74 b has a configuration complementary tothat of the helicoidal member 16 c at the helicoidal member proximal end20 to substantially snugly hold the helicoidal member 16 c. A pin 78(not shown in FIG. 9B) is insertable in a pin receiving passageway 80 bthat intersects the helicoidal thread 74 b and locks the helicoidalmember 16 c to the attachment 60 b, similarly to the manner in which thehelicoidal member 16 is locked to the attachment 60 a.

FIGS. 26 and 27 better illustrate various features of the system 10 atthe proximal end thereof. In some embodiments, a catheter end piece 128receives the catheter 36 at the catheter proximal end 38. The catheterend piece 128 defines an end piece passageway 129 (seen in FIG. 27) thatis in prolongation of the catheter lumen 42. The end piece passageway129 is threaded internally. The catheter end piece 128 is mountable to abase 130 in any suitable manner. The base 130 defines an end piece mount132 for removably mounting the catheter end piece 128 thereto. The endpiece mount 132 defines a mount aperture 134 extending therethrough inregister with the end piece passageway 129.

The driver actuator 62 is substantially tubular and provided withexternal threads 136 configured for engaging the threads of the endpiece passageway 129 and is long enough to protrude from the catheterend piece 128 and end piece mount 132 when inserted in the catheter 36.Rotating the driver actuator 62 thus advances or retracts the driveractuator 62 along the catheter 36 over the guide actuator 44.

When the system 10 is assembled, the coolant tube 54 is inserted in theguide actuator 44, which itself is inserted in the driver actuator 62,which itself is inserted in the catheter 36. Those components typicallyhave a generally cylindrical configuration and in embodiments in whichit is required, are flexible so as to allow bending of the catheter 36and components contained therein. The coolant source 50 is coupled tothe coolant tube 54 and guide actuator 44 through a coupler 140, whichmay support the bending actuator 47 when the latter is present. Thecoupler 140 is typically easily releasable from the coolant tube 54 andthe guide actuator 44 through a quick release coupler 142. This allowseasy removal of the driver actuator 62 to insert different helicoidalmembers 16 during a surgical procedure. The coupler 140 is alsoconfigured to suitably convey the coolant returning between the coolanttube 54 and guide actuator 44 to the coolant source 50 and convey thecold coolant coming from the latter to the coolant tube 54.

Referring to FIG. 11, in some embodiments a hook 88 is removablymountable to the helicoidal member 16 b. A suture thread 86 is securedto the hook 88. For example the hook 88 is crimped to the end of thesuture thread 86. In other embodiments (not shown in the drawings), thehook 88 defines a suture eye and a suture thread 86 is attachable to thesuture eye. In some embodiments, the helicoidal member 16 b is made of ahollow tube and the suture thread 86 extends through the helicoidalmember 16 b. The hook 88 has a part thereof insertable in the hollowtube at the helicoidal member distal end 22. For example, a hookattachment 89 part of the hook 88 is configured to be slidably insertedin the helicoidal member 16 b. The hook 88 is typically terminated by asharp point 90, as better seen in FIG. 12. In other embodiments, thehelicoidal member 16 c, seen in FIG. 13, defines a helicoidal groove 91therealong receiving the suture thread 86.

The hook 88 is configured so that the helicoidal member 16 b may beadvanced relatively easily in the target biological tissue 12 with thehook 88 remaining secured to the helicoidal member 16 b. The hook 88 isalso configured so that withdrawing the helicoidal member 16 b from thetarget biological tissue 12 causes the latter to catch the hook 88 sothat the hook 88 is detached from the helicoidal member 16 b or 16 c asthe target biological tissue 12 pulls on the hook 88. In theseembodiments, the driver 34 is further operative for retracting thehelicoidal member 16 b in a proximally oriented direction.

In some embodiments, the system 10 further includes an insert. Fourdifferent inserts 92 a, 92 b, 92 c and 92 d are shown in FIGS. 14, 15Aand B, 16A and B and 17A and B respectively. However, any other suitableinsert is usable. The inserts 92 a, 92 b, 92 c and 92 d are elementsthat are mountable to the guide 26 and engaged by the helicoidal member16. The inserts 92 a, 92 b, 92 c and 92 d and the guide 26 arelongitudinally movable relative to each other. The inserts 92 a, 92 b,92 c and 92 d are elements that are delivered along with the helicoidalmember 16 so that when the helicoidal member 16 remains in the targetbiological tissue 12, the helicoidal member 16 engages the insert 92 a,92 b, 92 c and 92 d, which is thus attached at the target tissue exposedsurface 14 after the helicoidal member 16 has been delivered anddetached from the driver 34. Such inserts 92 a, 92 b, 92 c and 92 d maybe used to secure a prosthesis to the target biological tissue 12 orsimply to provide a smoother interface and/or biocompatibility betweenthe helicoidal member 16 an adjacent lumen or cavity.

Smoothening is advantageous for example in blood vessels or in the heartas this will reduce turbulence around the helicoidal member 16. Thissmooth insert outer line would also promote endothelial cells build up.In other embodiments, the insert 92 a, 92 b, 92 c and 92 d may be usedto deliver a drug or cells at the target biological tissue 12. Theinsert 92 a, 92 b, 92 c and 92 d can then have the drug or cellsembedded therein and be permeable to the drug or be bioresorbable. Suchinserts 92 a, 92 b, 92 c and 92 d may facilitate permanent implantationof the helicoidal member 16 in the target biological tissue 12 bypromoting healing and/or tissue growth.

Referring to FIG. 14, the insert 92 a includes a substantiallyresiliently deformable piece of material 94 a provided opposed to theperipheral surface cooled portion 32 and extending along the guide 26.For example, the insert 92 a is made of a foam and may have a lengththat is larger than that of the helicoidal member 16, as seen in FIG.14, or that is similar or shorter to that of the helicoidal member 16(not shown in the drawings). The insert 92 a has a shape that allowssnugly fitting to the guide 26 and the helicoidal member 16 is insertedthrough the insert 92 a. Rotation of the insert 92 a about thelongitudinal axis of the guide 26 is prevented by the non-cylindricalshape of the guide 26. In some embodiments, the insert 92 a is slightlycompressed when mounted on the guide 26 to further prevent such rotationor the insert 92 a can be secured to guide 26 with adhesive and isdislodged by force after the helicoidal member 16 penetrates the sleeveinsert 92 a. Thus, in some embodiments, the guide 26 with insert 92 asecured thereto are first positioned, without the helicoidal member 16engaging the insert 92 a, and then the helicoidal member 16 is advanced,thus engaging the the insert 92 a.

In some embodiments, a distally provided tether attachment 95 isprovided for attaching a tether 97 to the insert 92 a. In otherembodiments, the tether 97 extends integrally from the insert 92 a.

Referring to FIG. 15A, the insert 92 b includes a substantially tubularmembrane 94 b positioned over the guide peripheral surface 30. Themembrane 94 b is provided with apertures 96 in register with theperipheral surface cooled portion 32 of the guide 26 e to allowadhesion. The guide 26 e is similar to the guide 26, but includes asubstantially flat peripheral surface cooled portion 32 The membrane 94b is typically longer than the helicoidal member 16. In someembodiments, the insert 94 b is provided with a body 99 b made of asubstantially resiliently deformable material, as seen in FIG. 15B thatcan be engaged by the helicoidal member 16 (not shown in FIG. 15B).

Another type of insert 92 c is shown in FIGS. 16A and 16B. As seen inFIG. 16B, the guide 26 f usable with the insert 92 c defines a pair ofsubstantially longitudinally extending mounting grooves 100, opposed tothe peripheral surface cooled portion 32. The insert 92 c defines a pairof substantially longitudinally extending mounting rods 102 each mountedin a respective one of the mounting grooves 100, thus securing theinsert 92 c to the guide 26 f. The insert 92 c can be also engaged bythe helicoidal member 16.

FIGS. 17A and 17B illustrate the insert 92 d. As seen in FIG. 17B, theinsert 92 d includes a membrane 94 d positionable opposed to theperipheral surface cooled portion 32 and through which the helicoidalmember 16 (not shown in FIG. 17B) can be inserted. The insert 92 dincludes attachment loops 98 securing the membrane 94 d to the guide 26e, the attachment loops 98 extending circumferentially around the guide26 e at longitudinally spaced apart positions therealong.

FIG. 18A illustrates an alternative guide 106. The guide 106 is similarto the guide 26, except that adhesion with the target tissue exposedsurface 14 is made though suction. As such, in a system including theguide 106, the cooling subsystem 33 is omitted and the guide 106 ishollow and provided with radially extending suction apertures 108. Theguide 106 may be connected to a conventional suction apparatus 113 sothat suction can be selectively exerted through the suction apertures108. Such suction adheres the portion of the guide adjacent the suctionapertures 108 to any surface adjacent thereto. In other embodiments, asuction apparatus is not provided. Instead, each suction aperture 108leads to an enclosed deformable cavity. Deforming the cavity to increaseits volume then provides suction.

The guide 106 and suction apertures 108 can have various configurations.For example, a guide 106 a including a series of longitudinally spacedapart suction apertures 108 a having a substantially ellipsoidal shapeis shown schematically in FIG. 18B. A guide 106 b including a series oflongitudinally spaced apart suction apertures 108 a having asubstantially rectangular shape is shown schematically in FIG. 18B. Aguide 106 c including an array of spaced apart suction apertures 108 chaving a substantially circular shape is shown schematically in FIG.18D.

The transversal cross-sectional configuration of the guide 106 can alsohave various shapes. The guide 26 may also be replaced by guides havingsuch transversal configurations. FIGS. 19A to 19H illustrateschematically such transversal cross-sectional configurations. Thesuction surface 109 is the surface of the guide 106 through which thesuction apertures 108 extend. FIG. 19A illustrates a guide 106 d havinga substantially trapezoidal suction surface 109 d. FIG. 19B illustratesa guide 106 e having a substantially T-shaped suction surface 109 e.FIG. 19C illustrates a guide 106 f having a substantially flat suctionsurface 109 f, the guide 106 f having a substantially rectangulartransversal cross-sectional configuration. FIGS. 19D and 19E illustraterespectively guides 106 g and 106 h having a substantially flat suctionsurfaces 109 g and 109 h, the guides 106 g and 106 h having atransversal cross-sectional configuration corresponding to a portion ofa disc. FIG. 19F illustrates a guide 106 i having a substantially arcsegment shaped suction surface 109 i, the guide 106 i having asubstantially circular transversal cross-sectional configuration. Theguide 106 j of FIG. 19 includes two elements. The larger element, with agenerally half-moon shaped transversal cross-sectional configuration maybe structural and support a smaller element of similar configuration,but flipped so as to define an arc segment shaped suction surface 106 j.FIG. 19H illustrates a guide 106 k having a substantially arc segmentshaped and convex suction surface 109 k, the guide 106 k having atransversal cross-sectional configuration corresponding to a portion ofa disc. Other shapes for the guide 106 are also within the scope of theinvention.

FIG. 18E illustrates another embodiment of a guide 106 a using suctionto adhere to the tissue exposed surface 14. The guide 106 a is hollowand provided with the suction apertures 108. The guide 106 a is incommunication with a suction apparatus 113 (not shown in FIG. 18E, as inthe guide 106. A sleeve 111 covers the guide 106a. The sleeve 111 isdeformable and at least partially inserted in the suction apertures 108.The sleeve 111 may be sealed around the guide 106 a, or only sealed atthe edge of each suction aperture 108. The sleeve 111 preventsbiological material from entering the guide 26 g. When the sleeve 111 iscompletely sealed around the guide 106a, sterilization of the guide 106a is also facilitated.

The system 10 is usable in many surgical procedures. For example, thesystem 10 is usable to maintain in contact two sides of an incision topromote healing of the incision. To that effect, the helicoidal member16 may be inserted so that it intersects both sides of the incision andis then left in the target biological tissue 12 after being detachedfrom the driver 34. In other embodiments, the helicoidal member 16 b isused to thread the suture thread 86 between the two sides of theincision and is then withdrawn with the hook 88 remaining anchored inthe target biological tissue 12. After withdrawal, one can pull on thesuture thread to close the incision. In another example, the system 10is also usable in any procedure in which an anchor similar to thehelicoidal member 16 is to be implanted. Such procedures includeimplantation of the anchor alone in the target biological tissue 12, orto anchor a prosthesis to the target biological tissue 12, such as acardiac valve. The system 10 is for example usable to implant thehelicoidal member 16 in an annuloplasty procedure or to implant areplacement cardiac valve.

Generally speaking, referring to FIG. 20, the invention provides asurgical method 200 using one of the guides 26, 26 a, 26 b, 26 c, 26 d,26 e or 26 f or 106, or any other suitable guide, to assist in insertionof one of the helicoidal members 16, 16 a or 16 b in a target biologicaltissue 12. For ease of reference and to improve readability, the method200 will be described with reference to the helicoical member 16 andguide 26 only, with the understanding that other guides, described ornot in the present application, and other helicoidal members, describedor not in the present application, may be used. The method 200 starts atstep 205 and includes step 210 of abutting a substantiallylongitudinally extending portion of the guide 26 against the targettissue exposed surface 14 with the helicoidal member 16 mounted theretoso that at least a portion of the guide 26 is inserted in the helicoidalmember passageway 24 substantially parallel to the helicoidal memberlongitudinal axis 18. The method 200 also includes step 215 of adheringthe substantially longitudinally extending portion of the guide 26 tothe target tissue exposed surface 14 and step 220 of advancing thehelicoidal member 16 in the target biological tissue 12 in asubstantially helicoidal movement with the guide 26 remainingsubstantially fixed relative to the target biological tissue 12. Finallythe method 200 also includes in some embodiments step 225 of completingthe procedure and ends at step 230.

Step 225 depends on the exact surgical procedure performed. In someembodiments, step 225 includes detaching the helicoidal member 16 fromthe driver 34 so that the former remains implanted in the targetbiological tissue 12 and detaching the guide 26 from the target tissueexposed surface 14 with the helicoidal member 16 remaining in the targetbiological tissue 12. In some embodiments, step 225 also includesdelivering the insert 92 a, 92 b, 92 c or 92 d while advancing thehelicoidal member 16 so that when the helicoidal member 16 remains inthe target biological tissue 12, the insert 92 a, 92 b, 92 c or 92 dengaging the helicoidal member 16 to be secured to the target biologicaltissue 12.

In other embodiments, step 225 includes withdrawing the helicoidalmember 16 b from the target biological tissue 12 so that the hook 88hooks the target biological tissue 12 and the suture thread 86 remainsin the target biological tissue 12. In these embodiments, the helicoidalmember 16 b is used to insert the suture thread 86 in a helicoidalconfiguration in the target biological tissue 12. Step 225 may then alsoinclude pulling on the suture thread 86 to tighten the suture thread 86.This action may compress parts of the target biological tissue 12. Thisaction may also bring together two sides of an incision or other openingin the target biological tissue 12.

Step 210 may include many actions. For example, in the case oftranscatheter procedures, step 210 includes positioning the catheter 36in a conventional manner at a location suitable to perform thetranscatheter procedure and then inserting the guide 26 with thehelicoidal member 16 positioned at least partially thereonto through thecatheter 36 so that the guide 26 is adjacent to the target tissueexposed surface 14, at a predetermined location. Then, the catheter 36can be moved to cause contact between the target tissue exposed surface14 and the guide 26. This procedure can be guided in a conventionalmanner, for example through 3D echocardiography and fluoroscopy. In someembodiments, the guide 26 may be provided with a sensor, such as a forcesensor or electrical sensor, among other possibilities to detect contactwith the target tissue exposed surface 14. In some embodiments, step 210also includes adjusting the shape of the guide 26 before adhering thesubstantially longitudinally extending portion of the guide 26 to thetarget tissue exposed surface 14.

In some embodiments, the guide 26 is used for cryoadhesion. In thismethod, adhering the substantially longitudinally extending portion ofthe guide 26 to the target tissue exposed surface 14 includes cooling atleast part of the guide 26 to a predetermined temperature, using thecooling subsystem 33. The predetermined temperature is low enough tocause cryoadhesion between the substantially longitudinally extendingportion of the guide 26, in this case part of the peripheral surfacecooled portion 32, and the target tissue exposed surface 14. In someembodiments, the predetermined temperature is low enough to allowcryoadhesion, but remains high enough and is applied for a durationshort enough that substantially no irreversible physiological damagesare caused to the target biological tissue 12. In other embodiments,some irreversible physiological damages may be caused to the targetbiological tissue 12. For example the predetermined temperature isbetween 0 and −40° C., or between −20 and −40° C.

Depending on the procedure to perform, the helicoidal member 16 may bedistally located relative to the longitudinally extending portion of theguide 26, proximally located relative to the longitudinally extendingportion of the guide 26 or at least partially in register with thelongitudinally extending portion of the guide 26. In some embodiments,the helicoidal member 16, 16 a or 16 b and guide 26 have substantiallysimilar lengths and are substantially in register with each other.

In other embodiments, the guide 106 is used and adhering thesubstantially longitudinally extending portion of the guide 106 to thetarget tissue exposed surface 14 includes exerting a suction through thesuction apertures 108, thus abutting the suction surface 109 against thetarget tissue exposed surface 109. In yet other embodiments, a guidesimilar to the guide 106 is used to inject through apertures similar tothe suction apertures 108 a temporary glue or polymer that adheres withtissues.

In some embodiments, the method 200 is performed during an annuloplastyprocedure, as illustrated schematically in the sequence of FIGS. 20A to20E and described in further details hereinbelow. In such embodiments,the target biological tissue 12 is a valve annulus 110 and/or tissueadjacent the valve annulus 110, for example a mitral valve annulus 110.In a specific embodiment, annuloplasty includes implanting at least twoof the helicoidal members 16 around the valve annulus 110 and tighteningthe valve annulus 110 by pulling the at least two helicoidal members 16towards each other, As illustrated in FIGS. 22B and 22C. The helicoidalmember 16 then has the same shape before and after insertion in thetarget tissue. In yet other embodiments, as illustrated in FIG. 22A, thehelicoidal member 16 goes around the whole valve annulus 110 in a closedloop, or partially around the valve annulus 110 in an arc segment shape,and tightening the valve annulus includes reducing a radius of curvatureof the helicoidal member 16.

In other embodiments, the helicoidal members 16 do not require pullingas they inherently allow tightening of the valve annulus 110. In onesuch embodiment, the helicoidal member 16 includes a shape memorymaterial and changes between a helicoidal member first configuration anda helicoidal member second configuration at a transition temperature,the transition temperature being between 20° C. and 37° C. Thehelicoidal member first and second configurations have differentpitches. In the case of annuloplasty, the helicoidal member secondconfiguration may have a smaller pitch than the helicoidal member firstconfiguration. In another example, the helicoidal member 16 a is used.The helicoidal member 16 a has a pitch that varies between thehelicoidal member proximal and distal ends 20 and 22. For example, thepitch is larger at the helicoidal member distal end 22 than at thehelicoidal member proximal end 20. In such embodiments, threading thehelicoidal member 16 a will compress the tissue to tighten the valveannulus.

A specific case of the method 200 used for installing an anchor or asuture around the mitral valve annulus 110 and cinching the latter toreduce its size are shown schematically from a top view in FIGS. 21A to21C. At first, as shown in FIG. 21A, the guide 26 is shaped andpositioned to match the mitral valve annulus 110 shape and position,corresponding to step 210. Once in place, as seen in FIG. 21B, adhesionis activated and the anchor, in the form of the helicoidal member 16, isadvanced over the guide 26 plunging into tissue, corresponding to steps215 and 220. FIG. 21C illustrates an embodiment in which a wire 112 ispre-attached to the guide 26. When the guide 26 is removed the wire 112tethers through the helicoidal member passageway 24. Once both end ofwire 112 are accessible, they are tightened and tension is maintained bya locking clip 115 that is advanced over a loop of the wire 112 passingthrough the helicoidal member 16. This effectively shrinks the radius ofcurvature of the helicoidal member 16 and in consequence the orificesize for the valve.

In other embodiments, as seen in FIGS. 21D and 21E, the wire 112 has aclip 115 at its free extremity that prevents the wire end to go throughthe helicoidal member 16 (by being too large to enter the helicoidalmember passageway 24 thus allowing to cinch the helicoidal member 16 byonly pulling on one end of the wire112. In some cases to reduce any gapsthat can persist between wire 112, helicoidal member 16 and targetbiological tissue 12, a bigger wire diameter is used with an expansioncapabilities provided by foam type material. This reduces possible blooddamage created by sharp edges and small gaps. In yet another embodiment,as seen in FIG. 21 F, the helicoidal member 16 b is removed, leaving inplace the suture thread 86 and hook 88 running along the path ofanchoring. When the suture thread 86 is pulled, the same area reductionas in FIGS. 21A to 21E may be achieved, albeit with less parts remaininginside the patient.

In other embodimends, the wire that tightens the helicoidal members 16doesn't form a loop, so each helicoidal members 16 can be tightenedindividually, i.e. the wire is attached to the distal end of an insert92 a to 92 d, and a pull on the proximal end of the wire with a lockingclip will reduce the size of the wire thus reducing the size of thehelicoidal member 16.

FIGS. 24A to 24D illustrate some steps of this process in a differentorientation, with the guide 26 viewed head on. In FIG. 24A, the guide 26is positioned adjacent to the mitral valve annulus 110. Then, as shownin FIG. 24B, the guide 26 is adhered to the mitral valve annulus 110 andthe helicoidal member 16 is advanced on the guide 26, as shown in FIGS.24C and 24D. FIGS. 24A to 24D illustrate the guide 26 positioned in theatrium. As shown in FIG. 24E, the guide 26 may also be positioned in theventricle.

FIGS. 23A to 23D illustrate the attachment of a prosthesis in the formof a valve 114 (shown in FIG. 23A for example) or 114 a (shown in FIG.23C for example) at the valve annulus 110. The valves 114 and 114 a aretypically secured the the valve annulus 110 while the biologicaldefective valve is left in place. However, in other embodiments, thebiological defective valve may be removed before the valve 114 or 114 ais attached.

Referring to FIG. 23D, the valve 114 includes a valve leaflet 116secured to a leaflet support 118. The leaflet support 118 has forexample a substantially ellipsoidal transversal cross-sectionalconfiguration and is substantially elongated. The leaflet support 118may be provided, in some embodiments, with a central wire 120 usable toadjust its shape prior or after implantation. The leaflet support 118 issecured to a guide 26 e defining a substantially flat valve supportingsurface 122, opposed to the peripheral surface cooled portion 32. Theleaflet support 118 also defines a substantially flat leaflet supportattachment surface 124 facing the valve supporting surface 122 andsecured thereto in any suitable manner, for example through a relativelyweak adhesive or by using a few spaced apart circular wires going aroundthe guide 26 e (not shown in the drawings), among other possibilities.

As shown in FIG. 23A, the valve 114 is positioned substantially adjacentthe valve annulus 110, for example in the atrium. The guide 26 e hasbeen omitted from FIG. 23A but is usually present. In some embodiments,two guides 26 e are used to anchor the leaflet support 118 from bothends thereof simultaneously, each with a respective helicoidal member16. However, using a single helicoidal member 16 is also within thescope of the invention. Once the valve 114 is suitably positioned, thehelicoidal member(s) 16 is (are) advanced over the leaflet support 118and into the tissue adjacent the valve annulus 110. The resultingconfiguration is illustrated schematically in FIG. 23B. In otherembodiments, a tubular valve 114 a, partially shown in FIG. 23C is usedinstead, but the remainder of the process is similar to the processdescribed for valve 114.

More specifically, referring to FIG. 23E, a pair of guides 26 arcing inopposed directions are positioned adjacent the valve annulus 110. Then,the tubular valve 114 a is positioned over the pre-existing valve, andthe helicoidal members 16 are each advanced over a respective guide 26to anchor the valve 114 a to the adjacent tissue, as seen in FIG. 23F.Finally, as seen in FIG. 23G, the guides 26 are removed with thehelicoidal members 16 remaining anchored in the patient. The tubularvalve 114 a is better seen in FIG. 23H. For delivery, the tubular valve114 a is rolled to form a generally annular shape and then folded inhalf with each half secured to a respective guide 26. When exiting thecatheter 36, the guides 26 deploy, forming the shape shown in thedrawings and the valve 114 a unrolls.

In yet another example, placating two pieces of tissue together by meansof the system 10 is illustrated schematically in FIGS. 25A to 25H. Inthis embodiment, the hook 88 and suture thread 86 are used. The guide 26is first suitably positioned and adhered to the target biological tissue12, in this case between two tissue portions 13, and the helicoidalmember 16 b is advanced over both tissue portions 13, as seen in FIGS.25A and 25B. Then, the helicoidal member 16 b is withdrawn leaving inplace the suture thread 86, as see in the sequence of FIGS. 25C, 25D and25E. Subsequently, the guide 26 is removed and the continuous suturethread 86 is left in place, as seen in FIG. 25F. To further reduce andeliminate any distance therebetween and secure both tissue portions 13to each other, the suture thread 86 is pulled on as illustrated in FIGS.25G and 25H.

The system 10 is manufactured using materials commonly used in thebiomedical industry, such as stainless steel and polymers.

Although the present invention has been described hereinabove by way ofpreferred embodiments thereof, it can be modified, without departingfrom the spirit and nature of the subject invention as defined in theappended claims.

What is claimed is:
 1. A surgical method using a guide to assist ininsertion of a helicoidal member in a target biological tissue, thetarget biological tissue defining a target tissue exposed surface, thehelicoidal member defining a helicoidal member longitudinal axis andsubstantially longitudinally opposed helicoidal member proximal anddistal ends, a helicoidal member passageway extending longitudinallybetween the helicoidal member proximal and distal ends, the guide beingsubstantially elongated and defining a guide tip, the method comprising:abutting a substantially longitudinally extending portion of the guideagainst the target tissue exposed surface with the helicoidal membermounted thereto so that at least a portion of the guide is inserted inthe helicoidal member passageway substantially parallel to thehelicoidal member longitudinal axis; adhering the substantiallylongitudinally extending portion of the guide to the target tissueexposed surface with the helicoidal member longitudinal axissubstantially parallel to the target tissue exposed surface; andadvancing the helicoidal member in the target biological tissue in asubstantially helicoidal movement with the guide remaining substantiallyfixed relative to the target biological tissue.
 2. The method as definedin claim 1, wherein adhering the substantially longitudinally extendingportion of the guide to the target tissue exposed surface includescooling at least part of the guide to a predetermined temperature, thepredetermined temperature being low enough to cause cryoadhesion betweenthe substantially longitudinally extending portion of the guide and thetarget tissue exposed surface.
 3. The method as defined in claim 2,wherein the predetermined temperature is low enough to allowcryoadhesion, but remains high enough and is applied for a durationshort enough that substantially no irreversible physiological damagesare caused to the target biological tissue.
 4. The method as defined inclaim 2, wherein the predetermined temperature is between 0° C. and −40°C.
 5. The method as defined in claim 1, wherein the guide includessuction apertures in the substantially longitudinally extending portionof the guide and wherein adhering the substantially longitudinallyextending portion of the guide to the target tissue exposed surfaceincludes exerting a suction through the suction apertures.
 6. The methodas defined in claim 1, wherein the helicoidal member is between theguide tip and the substantially longitudinally extending portion of theguide before adhering the substantially longitudinally extending portionof the guide to the target tissue exposed surface.
 7. The method asdefined in claim 1, wherein the substantially longitudinally extendingportion of the guide is between the guide tip and helicoidal memberbefore adhering the substantially longitudinally extending portion ofthe guide to the target tissue exposed surface.
 8. The method as definedin claim 1, wherein the substantially longitudinally extending portionof the guide and the helicoidal member have at least portions thereofsubstantially in register with each other before adhering thesubstantially longitudinally extending portion of the guide to thetarget tissue exposed surface.
 9. The method as defined in claim 1,further comprising detaching the guide from the target tissue exposedsurface with the helicoidal member remaining in the target biologicaltissue and removing the guide from within the helicoidal memberpassageway.
 10. The method as defined in claim 9, further comprisingdelivering an insert while advancing the helicoidal member so that whenthe helicoidal member remains in the target biological tissue, thehelicoidal member engages the insert.
 11. The method as defined in claim10, wherein the insert includes a membrane.
 12. The method as defined inclaim 10, wherein the insert includes a resiliently deformable material.13. The method as defined in claim 9, further comprising delivering aprosthesis while advancing the helicoidal member so that when thehelicoidal member remains in the target biological tissue, theprosthesis is secured to the target biological tissue by the helicoidalmember.
 14. The method as defined in claim 13, wherein the prosthesisincludes a cardiac valve.
 15. The method as defined in claim 1, whereinthe helicoidal member supports a distally provided hook to which asuture thread is secured, the hook being removable from the helicoidalmember, the method further comprising using the helicoidal member toinsert the suture thread in a helicoidal configuration in the targetbiological tissue; withdrawing the helicoidal member from the targetbiological tissue with the hook hooking the target biological tissue sothat the hook and suture thread remain in the target biological tissue;and pulling on the suture thread to tighten the suture thread.
 16. Themethod as defined in claim 1, further comprising positioning the guideat a predetermined location along the target tissue exposed surfacebefore adhering the substantially longitudinally extending portion ofthe guide to the target tissue exposed surface.
 17. The method asdefined in claim 1, further comprising adjusting the shape of the guidebefore adhering the substantially longitudinally extending portion ofthe guide to the target tissue exposed surface.
 18. The method asdefined in claim 1, further comprising inserting a catheter in a mammalin which the target biological tissue is located so that a catheterdistal tip of the catheter is substantially adjacent the target tissueexposed surface; and advancing the guide in the catheter until at leastpart of the guide protrudes from the guide.
 19. The method as defined inclaim 1, wherein the target biological tissue is a valve annulus. 20.The method as defined in claim 19, comprising implanting at least two ofthe helicoidal members around the valve annulus and tightening the valveannulus by pulling the at least two helicoidal member towards eachother.
 21. The method as defined in claim 19 wherein the method includesimplanting the helicoidal member around the valve annulus and tighteningthe valve annulus by reducing a radius of curvature of the helicoidalmember.
 22. The method as defined in claim 19 wherein the valve annulusis a mitral valve annulus.
 23. The method as defined in claim 1, whereinthe helicoidal member has the same shape before and after insertion inthe target biological tissue.
 24. The method as defined in claim 1,wherein the helicoidal member includes a shape memory material, thehelicoidal member changing between a helicoidal member firstconfiguration and a helicoidal member second configuration at atransition temperature, the transition temperature being between 20° C.and 37° C.
 25. The method as defined in claim 24, wherein the helicoidalmember first and second configurations have different pitches.
 26. Themethod as defined in claim 1, wherein the helicoidal member has a pitchthat varies between the helicoidal member proximal and distal ends. 27.The method as defined in claim 26, wherein the pitch is larger at thehelicoidal member distal end than at the helicoidal member proximal end.28. The method as defined in claim 5, wherein the guide is inserted in adeformable sleeve, the sleeve being partially inserted in the suctionapertures.
 29. The method as defined in claim 1, where the substantiallylongitudinally extending portion of the guide adhered to the targettissue exposed surface is at the guide tip.
 30. The method as defined inclaim 1, where the substantially longitudinally extending portion of theguide adhered to the target tissue exposed surface is spaced aparttherefrom longitudinally from the guide tip.